技能/経験

■Quality Specific Goals
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals , and applicable laws and regulations (GQP ministry ordinance) as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Ensure on-time reporting of the metrics for quality management reviews.

■Qualifications/Requirements
- B.S. Degree in bioscience, chemistry, pharmaceutical, or technical field
- At least 7 years of experience in pharmaceutical and/or healthcare products industry or other regulated industry
- At least 3-5 years of QA experience in a pharmaceutical and/or healthcare products manufacturing environment and/or country office affiliate operations environment (at least 3 years in a supervisory or managerial role)
- Proficient with MS Office word processing, spreadsheet, presentation, and database applications
- Proficient with eQMS and eDMS systems, for example TrackWise and Veeva Vault respectively
- Proficient with ERP/WMS systems such as SAP
- Proficient with teleconferencing software platforms (MS Teams)
- Ability to identify root cause of problem and creatively problem solve to gain resolution.
- Ability to work independently in fast-paced environment with little supervision.
- Ability to adapt to constant change and influence positive change effectively. - - Team-oriented, with experience in work with cross-functional teams across local and global scope and responsive to customer needs
- Quality-focused, attentive to detail and results-oriented
- Ability to communicate effectively in Japanese and business level of English (both written and oral)
- Strong managerial, people guidance, project management and time-management skills
- Strong analytical, logical and critical thinking skills and abilities

■Desired Characteristics
- Pharmacist (preferred but not mandatory for Hinseki track, mandatory for Sokatsu track)
- Experience being in Hinseki and/or Sokatsu roles
- People leading/managing experience
- Working experience in MNC pharmaceutical/healthcare product organizations
- Experiences with CA/PA systems (GEHC electronic QA system)
- Experiences applying regulations (GMP, GDP, GQP)
- QC testing experience for sterile products
- Technical transfer experience for QC test or manufacturing process for sterile products